Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Renee Stapleton, University of Vermont
ClinicalTrials.gov Identifier:
NCT01558817
First received: February 21, 2012
Last updated: February 15, 2013
Last verified: February 2013

February 21, 2012
February 15, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
Cardiopulmonary Resuscitation Preference [ Time Frame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention ] [ Designated as safety issue: No ]
The primary outcome will be the difference in the proportion of patients in the informed assent intervention and informational brochure groups reporting preferences to be DNR (do not rescusitate).
DNR (do not resuscitate) Status Preference before and after intervention [ Time Frame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention ] [ Designated as safety issue: No ]
The primary outcome will be the difference in the proportion of patients in the informed assent intervention and informational brochure groups reporting preferences to be DNR.
Complete list of historical versions of study NCT01558817 on ClinicalTrials.gov Archive Site
  • Depression [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ] [ Designated as safety issue: No ]
    Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.
  • Anxiety [ Time Frame: Baseline (day of intervention) and two weeks after intervention ] [ Designated as safety issue: No ]
    Patients and families will complete the GAD-7 questionnaire, a measure of generalized anxiety disorder.
  • Physician Order for Life Sustaining Treatment (POLST) [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ] [ Designated as safety issue: No ]
    Participants who expressed a preference to be DNR will be asked to complete a POLST form by their physician. It will also be explained that this can be changed any time the status changes.
  • DNR status preference [ Time Frame: Two weeks after the intervention ] [ Designated as safety issue: No ]
    The difference in DNR status preference between patients in the control and invervention group at two weeks after the intervention.
  • Report on acceptability of the informed assent approach [ Time Frame: Within couple of hours (up to 2 weeks) after intervention ] [ Designated as safety issue: No ]

    The following questions will be asked:

    1. How helpful was this approach to discussing CPR with respect to CPR decisions?
    2. Would you recommend this approach to discussing CPR for other patients who have serious illnesses?
  • Assessment of DNR status change or intervention follow-up from primary physician [ Time Frame: Three months after the intervention ] [ Designated as safety issue: No ]
    Contact the physician for each patient at 3 months after the study visit to determine whether there are changes in the DNR status or if the physician has talked with the patients about the status since the study visit.
  • Resource utilization [ Time Frame: Up to 6 months after intervention or until death ] [ Designated as safety issue: No ]
    Record resource utilization for participants that includes hospitalizations, ICU care, use of hospice etc by medical record review.
Same as current
Not Provided
Not Provided
 
Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent
Not Provided

Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic cancer. Recent work found that in-hospital CPR is being performed more often before death with unchanging survival and that fewer CPR survivors are being discharged home, thus suggesting that CPR is increasingly performed without benefit and that the burden of this ineffective treatment is increasing. Unlike other medical procedures, CPR has become the default provided to all patients even those with tremendously poor outcomes. It is time to change the paradigm of CPR. Through comparing an innovative "informed assent" approach toward in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a group of chronically ill patients with reduced life expectancy, the investigators aspire to demonstrate that CPR delivery can be reduced. And in addition that DNR status increases, while preserving patient quality of life and decreasing the burden of this ineffective treatment to both patients and families. If effective, this informed assent intervention has the potential to revolutionize how the investigators discuss CPR with the investigators chronically ill patients.

Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Oxygen Dependent COPD
  • Advanced Malignancy
  • Behavioral: Informed Assent
    Patients receive informed assent approach toward in-hospital CPR outcomes. Patients are informed that their underlying chronic illness makes outcomes after CPR so poor that CPR is not performed while allowing them to disagree.
  • Behavioral: Informational Brochure
    An informational brochure about CPR will be given without a discussion with a physician.
  • Active Comparator: Informational brochure
    Patients receive an informational brochure
    Intervention: Behavioral: Informational Brochure
  • Experimental: Intervention
    Patients receive physician-directed informed assent intervention regarding CPR and informational brochure.
    Intervention: Behavioral: Informed Assent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Oxygen dependent COPD or Advanced Malignancy
  • Life expectancy of less than two years

Exclusion Criteria:

  • Subjects who have already firmly decided to undergo CPR
  • Subjects enrolled in a hospice program
  • Subjects unable to speak English
  • Subjects incapable of making their own decisions at the time of enrollment
  • Subjects cared for by the study investigator
Both
18 Years and older
No
Contact: Renee Stapleton, MD, PhD 802-656-7975 renee.stapleton@uvm.edu
United States
 
NCT01558817
PilotCPR001
Yes
Renee Stapleton, University of Vermont
University of Vermont
Not Provided
Not Provided
University of Vermont
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP